• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN SURGICAL SA MANIPLER AZ - 35W SKINSTAPLER SKIN STAPLER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B. BRAUN SURGICAL SA MANIPLER AZ - 35W SKINSTAPLER SKIN STAPLER Back to Search Results
Model Number 783100
Device Problems Mechanical Problem (1384); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: evaluation on-going. Date of event: unknown. Pending further information.

 
Event Description

It was reported by the healthcare professional to the company sales representative "the stapler staples do not close, which prevents the wound from closing. The postoperative wound was closed with the help of the fifth stapler. This made the patient lengthen of surgery and the hospital stay prolonged. " outcome of the patient unknown. Length of delay of surgery unknown.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMANIPLER AZ - 35W SKINSTAPLER
Type of DeviceSKIN STAPLER
Manufacturer (Section D)
B. BRAUN SURGICAL SA
121 carretera de terrassa
rubi, 08191
SP 08191
Manufacturer (Section G)
B. BRAUN SURGICAL SA
121 carretera de terrassa
rubi, 08191
SP 08191
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key7908023
MDR Text Key121701742
Report Number3003639970-2018-00622
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodePL
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number783100
Device Catalogue Number783100
Device LOT NumberU178030000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/18/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/25/2018
Event Location No Information
Date Manufacturer Received10/22/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/25/2018 Patient Sequence Number: 1
-
-